A New Method for Sham‐Controlled Acupuncture in Experimental Visceral Pain – a Randomized, Single‐Blinded Study

Abstract

The presented sham procedure provides a valid method for blinding of "sham acupuncture" and may be used in future blinded controlled trials of acupuncture for visceral pain.

Central and Peripheral Mechanism of Acupuncture Analgesia on Visceral Pain: A Systematic Review

“…Two studies included irritable bowel syndrome (IBS) patients [15, 16], and one study involved primary dysmenorrhea [17] and another study involved chronic pancreatitis patients [18]. Further, a study by Kotani et al [19] investigated postoperative visceral pain in patients who underwent upper or lower abdominal surgeries [18], and two studies involved healthy participants [20, 21] (Table 2).…”

“…Among the seven studies conducted on humans, the various types of acupuncture techniques that were used are as follows: MA in four studies [17–19, 21], acu-TENS in three studies [16, 17, 20], and EA in two studies [15, 17]. Most of these studies described the stimulation method that was used, the intensity (frequency, voltage, and amperage), and the locations of acupoints.…”

“…(3) Brain and Brain Stem . Functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) were used to measure neuronal activity in IBS patients [15] and healthy participants [18, 21]. The fMRI results showed significant increases in the brain activity in the thalamus and insula in the EA group compared to in the sham EA group [15], and there were no significant differences observed in the EEG data between the groups [18, 21] (Tables 2 and 5, Figure 3).…”

Double‐blind and single‐blind retractable placebo needles

“…When the blunt tip of the needle reaches the skin, the needle body is pushed into a hollow needle handle, hence blinding the patient but not the practitioner . Furthermore, the structure of single‐blind sham needle used in Juel's study , which has been cited by Choi and Lam , is different from the Streitberger and Park needles, and thus the sharp tip of a hollow inner tube provides patients with a pricking sensation .…”

Credible control groups and blinding

“…Placebo acupuncture needles are metallic retractable needles with blunt tips which can prick the skin, but are fitted with a stopper that prevents the needle from advancing further when it has reached the specified position. Therefore, the needle is not actually inserted into the flesh . Reports of the success of blinding using retractable acupuncture needles vary , but most well‐controlled studies have found them to be inadequate in blinding either the acupuncturist or the subjects, with up to 83% of acupuncturists and 68% of subjects correctly identifying which needles were being used .…”